New Drug Development

2017-03-15

One area of technology transfer from the research portfolio of CAMS and PUMC is obviously new drug development. In fact, developing new drugs, vaccines, or other types of medical intervention is the primary mandate for several research institutes at CAMS.

 

For instance, the Institute of Materia Medica (IMM) was started in 1958 with the goal of not only leading pharmacology research in China, but also of bringing new drugs into clinical use.

 

IMM has established a system to streamline its commercialization and research cycle. This includes sending a drug that is commercialization-ready to a dedicated engineering center affiliated with IMM, where a process for largescale production is developed. Once this process is validated and tested, the new drug enters the regulatory approval pipeline and is moved into marketlevel production and initiated at one of the IMM-affiliated pharmaceutical companies, such as Beijing Union Pharmaceuticals. Marketed drugs not only bring in additional funding to IMM through patent fees and royalties, but the integrated commercialization system also feeds market information back to IMM researchers to help shape future drug development strategies.

 

IMM’s achievements are impressive. Currently, 53 domestic and international patent applications from IMM are pending, and 33 drug patents have been authorized. The total number of new drug patents obtained by IMM is now over 700. The range of commercialized products from IMM is broad, including compound drugs based on natural products or traditional Chinese medicine regimens, synthetic small-molecule drugs, and active pharmaceutical ingredients. 

 

IMM has established a tried and tested network of affiliated or associated pharmaceutical entities that support the commercialization process in China. IMM primarily utilizes two directly affiliated Beijing Union Pharmaceuticals companies, and has major stakes in three domestic manufacturers, one of which specializes in the production of synthetic musk developed at IMM. In addition, IMM has also collaborated with a constellation pharmaceutical companies, including Bayer, Roche, Sanofi, Pfizer, and Lilly, to make novel drugs developed in China available on the international market. 

 

Apart from IMM, other CAMS and PUMC research institutes also participate in more specialized areas of new drug development and commercialization. The Institute of Medicinal Biotechnology, for instance, develops antimicrobial agents. Today, the institute actively develops antibiotics, antivirals, and antitumor treatments.

 

The Institute of Medical Biology (IMB) in Kunming, Yunnan Province, was originally a virology laboratory for polio vaccine development. Today, IMB has become the center of vaccine research, development, and commercialization in China. IMB integrates industry, academics, and research, and currently have more than 100 staff members working on new vaccines in several disease areas. A unique strength of IMB is the primate animal facility, which allows complex pharmacology testing not feasible in small laboratory animals such as mice and rats. 

 

With many ongoing drug development programs, the need for animal model testing in the preclinical stage is great. CAMS and PUMC have set up a dedicated institute to develop animal models for clinically relevant problems and rapid testing of new treatments. This institution develops animal models to support preclinical research and drug development in CAMS and PUMC. It also advises and supports the government during pandemic emergencies, such as the 2003 SARS (severe acute respiratory syndrome) outbreak, and assists with accelerated drug or vaccine validation.